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Randomized Controlled Trial Multicenter Study
Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolaevulinic acid 20% vs. two-stage topical methyl aminolaevulinate: results of a randomized controlled trial.
- J P H M Kessels, H Kreukels, P J Nelemans, M H Roozeboom, H van Pelt, K Mosterd, de Haas E R M ERM Department of Epidemiology, Maastricht University, Maastricht, the Netherlands., and Kelleners-Smeets N W J NWJ Department of Dermatology, Maastricht University Medical Centre, Maastricht, the Netherlands. .
- Department of Dermatology, Maastricht University Medical Centre, Maastricht, the Netherlands.
- Br. J. Dermatol. 2018 May 1; 178 (5): 1056-1063.
BackgroundBasal cell carcinoma (BCC) is the most common type of skin cancer and incidence rates are increasing. Photodynamic therapy (PDT) is a frequently used treatment, especially for superficial BCC (sBCC). Two topical photosensitizing agents are currently used to treat sBCC, namely 5-aminolaevulinic acid (ALA) and its ester, methyl aminolaevulinate (MAL). Previous research showed a high efficacy for ALA-PDT using a twofold fractionated illumination scheme in which two light fractions of 20 J cm-2 and 80 J cm-2 were delivered 4 h and 6 h after ALA application.ObjectivesTo evaluate whether twofold ALA-PDT is superior to conventional MAL-PDT for sBCC.MethodsWe performed a single-blind, randomized, multicentre trial in the Netherlands.ResultsOverall, 162 patients were randomized either to conventional MAL-PDT or twofold ALA-PDT. After 12 months, a total of six treatment failures occurred following ALA-PDT and 13 treatment failures occurred following MAL-PDT. The 12-month cumulative probability of remaining free from treatment failure was 92·3% [95% confidence interval (CI) (83·7-96·5)] for ALA-PDT and 83·4% (95% CI 73·1-90·0) for MAL-PDT (P = 0·091).ConclusionsThe twofold ALA-PDT scheme resulted in fewer recurrences, although the difference between both treatment groups was not statistically significant. However, ALA-PDT resulted in higher pain scores and more post-treatment side-effects compared with MAL-PDT.© 2017 British Association of Dermatologists.
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